Zola-cel (BMS-986353) by Bristol Myers Squibb: status and timeline

Zola-cel (BMS-986353)

Replace lifelong immune-suppressing drugs in severe lupus, scleroderma and other autoimmune diseases with a single treatment that leads to drug-free remission.

PilotStage 3 of 5

Phase 2 in lupus; enrollment paused Aug 2026 after inflammatory events. Scleroderma Phase 3 due 2027.

Updated 31 Aug 2026Checked 11 Oct0 updates this week

Milestones

Next · Enrollment paused after inflammatory events

Breakfree-1 Phase 1 starts13 Sep 2023Complete.
Breakfree-2 starts in multiple sclerosis and myasthenia gravis28 Mar 2024Complete.
Phase 2 Breakfree-SLE starts in lupus14 Jul 2025Complete.
Phase 1 data on 71 patients at ACR Convergence25 Oct 2025Complete.
Enrollment paused after inflammatory eventsTarget 31 Aug 2026Current milestone.
Phase 3 Breakfree-SSc in scleroderma beginsTarget Feb 2027Not yet reached.

Most important updates

Upcoming

31 Aug 2026Enrollment paused after inflammatory events (next)
Feb 2027Phase 3 Breakfree-SSc in scleroderma begins

Current obstacles

Inflammatory side effectsBrief, reversible inflammatory events led BMS to pause enrollment in Aug 2026; one case of a rare hyper-inflammation syndrome was reported earlier.
Rival's deaths cloud the fieldNovartis halted eight trials of its autoimmune CAR-T after three deaths, raising the safety bar regulators will set for everyone.
Durability unprovenFollow-up is short. It is not yet known how long drug-free remission lasts or whether disease returns as B cells regrow.

Physics limits

Living drugs are hard to controlOnce infused, CAR-T cells multiply on their own. The dose in the body depends on each patient, so overactivation and cytokine storms can't be fully prevented.
Killing all B cells leaves a gapCD19 is on healthy B cells too, so treatment wipes out antibody production for months and raises infection risk until B cells regrow.
One patient, one batchEach dose is made from that patient's own cells, so cost and factory capacity scale with patients, unlike pills or antibodies made in bulk.

How it works

4 parts

Collect

Take the patient's T cells

White blood cells are drawn from the patient and sent to a factory, where T cells are isolated.

Engineer

Add a B-cell-seeking receptor

A gene for a receptor that locks onto CD19, a marker on B cells, is added. The cells are grown for about five days and frozen.

Infuse

Clear out B cells

After mild chemotherapy to make room, the cells are infused, multiply and kill B cells, including those making harmful self-antibodies.

Reset

Fresh B cells grow back

Months later new, naive B cells return. In early patients the disease stayed quiet without the usual immune drugs.

Spec sheet

Spec	Zola-cel (BMS-986353)
Target	CD19 on B cells^R (reported)
Manufacturing time	About 5 days (NEX-T)^R (reported)
Breakfree-1 patients (Oct 2025)	71 treated^R (reported)
Off long-term immune drugs	94% of evaluable patients^R (reported)
Breakfree-SLE enrollment	89 patients (planned)^R (reported)
Breakfree-SSc enrollment	92 patients (planned)^R (reported)

^R reported by the company

Papers & demos

1 item

25 Oct 2025talk
Breakfree-1 Phase 1 results in lupus, scleroderma and myositis at ACR Convergence 2025 (opens news.bms.com)71 treated patients; first broad look at zola-cel's immune-reset effect and side effects.

Update log

3 updates

About Bristol Myers Squibb

The team behind Zola-cel (BMS-986353)

Bristol Myers Squibb

CAR-T cell therapies, cancer and immunology drugs

Bristol Myers Squibb is a large US drugmaker that sells two approved CAR-T cell therapies for blood cancers, Breyanzi and Abecma. It is now testing a CAR-T, zola-cel, meant to reset the immune system in lupus, scleroderma and other autoimmune diseases.

Sells two approved CAR-T therapies for blood cancers, Breyanzi and Abecma, both gained with its 2019 purchase of Celgene (which owned Juno).
Zola-cel kept 94% of evaluable early autoimmune patients off long-term immune drugs; new enrollment paused late Aug 2026.
Bought Orbital Therapeutics for $1.5B in Oct 2025 to make CAR-T cells inside the body instead of in a lab.

bms.com (opens bms.com)Company profile →

Founded: 1887139 yrs
Headquarters: United States
Status: Public
Listed: BMY (opens google.com)NYSE
Valuation: public
Staff: ~32,500Jan 2025
Works in: BiotechCell & organ therapies
Coverage: 1 program · 4 updateslatest 31 Aug 2026checked 11 Oct
Partners: BioNTech (opens pharmaceutical-technology.com)
People: Chris BoernerChairman and CEOLynelle B. HochPresident, Cell Therapy Organization

Spec

Zola-cel (BMS-986353)

Target

CD19 on B cells^R (reported)

Manufacturing time

About 5 days (NEX-T)^R (reported)

Breakfree-1 patients (Oct 2025)

71 treated^R (reported)

Off long-term immune drugs

94% of evaluable patients^R (reported)

Breakfree-SLE enrollment

89 patients (planned)^R (reported)

Breakfree-SSc enrollment

92 patients (planned)^R (reported)

Zola-cel (BMS-986353)

Milestones

Most important updates

Upcoming

Current obstacles

Physics limits

How it works

Take the patient's T cells

Add a B-cell-seeking receptor

Clear out B cells

Fresh B cells grow back

Spec sheet

Papers & demos

Update log

Mon 31 Aug

Sat 25 Oct 2025

Mon 14 Jul 2025

About Bristol Myers Squibb

Current obstacles

Physics limits

How it works

Take the patient's T cells

Add a B-cell-seeking receptor

Clear out B cells

Fresh B cells grow back

Spec sheet

Papers & demos

Update log

Mon 31 Aug

Sat 25 Oct 2025

Mon 14 Jul 2025

About Bristol Myers Squibb